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BioWorld - Tuesday, December 23, 2025
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Home » Guardant wins over an FDA advisory panel for Shield CRC test
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Guardant wins over an FDA advisory panel for Shield CRC test

May 24, 2024
By Mark McCarty
The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance regarding adenoma, the advisory committee voted 6-3 that the benefits outweigh the risks in a decision the FDA is likely to affirm.
BioWorld MedTech Regulatory Cancer Oncology Diagnostics U.S. FDA

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